PEPGEN P-15 PUTTY
Received Sep 19, 2007 · Event occurred Aug 7, 2007
Report 1721411-2007-00158 · MDR key 915304
Device
Product problems
- Explanted
- Failure to Osseointegrate
Patient
51 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN THIS EVENT, PEPGEN P-15 PUTTY AND PUROS (NOT MANUFACTURED BY DENTSPLY) WERE USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE LEFT POSTERIOR MAXILLA WITH BONE QUALITY TYPE II AND FAIR ORAL HYGIENE. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS TRANSGINGIVAL FOR A ONE-STAGE TREATMENT APPROACH. THE IMPLANT DID NOT OSSEOINTEGRATED AND HAD SIGNS OF MOBILITY AND PERI-IMPLANTITIS UPON EXPLANTATION APPROXIMATELY THREE WEEKS POST-PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT, THOUGH THE HEALING TIME IS TOO SHORT TO EXPECT COMPLETE INTEGRATION.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.